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Recruiting NCT07219992

Parent-Based Treatment for Adolescent Anxiety

No phase Interventional Anxiety Disorder of Adolescence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supportive Parenting for Anxious Childhood Emotions (SPACE), Parent Educational Support (PES).
Who it may be relevant to
Registry conditions: Anxiety Disorder of Adolescence. Basic parameters: 14 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Testing a Novel Parent-Based Treatment for Adolescent Anxiety Disorders

Overview

This study aims to test the efficacy of a parent-only approach to treating anxiety disorders in adolescents: SPACE (Supportive Parenting for Anxious Childhood Emotions). The comparator is another parent-based approach, PES (Parent Education and Support). The study design is a randomized controlled trial with 2 treatment arms and 3 assessment points (pre, post, and follow-up) using questionnaire data and clinical interviews.

Detailed description

The primary objective is to examine if SPACE is more efficacious than PES in reducing adolescent anxiety symptoms. The secondary objective is to examine if SPACE produces greater change than PES in improving family accommodation and family functioning.

SPACE and PES will be delivered over 12 sessions: Sessions 1-6 (once weekly), a mid-treatment assessment, Sessions 7-12 (once weekly), and a Post-treatment assessment.

Sessions can be attended in person or via Zoom.

Interventions

  • Behavioral Supportive Parenting for Anxious Childhood Emotions (SPACE)
    Parent based treatment delivered by a therapist 12 weekly sessions with parents.
  • Behavioral Parent Educational Support (PES)
    Parent Educational Support: 12 weekly sessions with parents

Primary outcome measures

  • Mean Pediatric Anxiety Rating Scale (PARS) score [Time frame: Week 1 and 14]
  • Mean Screen for Child Anxiety Related Emotional Disorders (SCARED-C/P) score [Time frame: Week 1, 7 and 14]
  • Mean Child Anxiety Impact Scale (CAIS-C/P) score [Time frame: Week 1 and 14]
  • Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) scales score [Time frame: Week 1 and 14]
Secondary outcome measures (4)
  • Mean Family Accommodation Scale - Anxiety (FASA-C/P) score [Time frame: Week 1, 8 and 14]
  • Mean Family Assessment Device - General Functioning Scale (FAD-GF) score [Time frame: Week 1 and 14]
  • Mean Parent Problem Checklist scale score [Time frame: Week 1 and 14]
  • Mean Parent Behavior Inventory - Child and Parent Report (CRPBI/PRPBI) scale score [Time frame: Week 1 and 14]

Eligibility criteria

Inclusion criteria

  • Meet criteria for a primary DSM-5 AD, including separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, specific phobia, panic disorder, and agoraphobia (determined by the ADIS-C/P).
  • Cease all other psychosocial treatment, upon consultation with the project staff and service provider.
  • Not currently use any psychotropic medication, other than a stable dose (i.e., same dose for a minimum of 6 months prior to enrollment; no changes during course of the study) of a stimulant medication or selective serotonin reuptake inhibitor (SSRI).
  • Have an eligible and willing participating parent (see parent exclusions below).

Exclusion criteria

Adolescent:

  • Meet criteria for any DSM-5 disorder more impairing than the most impairing AD (determined by the ADIS-C/P).
  • Have any of the following disorders: autism spectrum disorder; intellectual disability; neurocognitive disorders; bipolar disorder; schizophrenia and other psychotic disorders; and alcohol and substance use disorders (determined by the Health History Form and ADIS-C/P).
  • Report a suicide attempt in the last 3 months, or current suicide intent and plans (determined by the ASQ).
  • Be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services.
  • Not have sufficient proficiency with the English language to complete assessments.

Parents:

  • Have any of the following: intellectual disability; neurocognitive disorders; untreated bipolar disorder; untreated schizophrenia and other psychotic disorders; and untreated alcohol and substance use disorders (determined by the Health History Form).
  • Not be living with the adolescent at least 50% of the time for at least one year prior to enrollment.
  • Not have sufficient proficiency with the English language to complete assessments and treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Yale Child Study Center — New Haven

Identifiers

NCT: NCT07219992 · 2000040413

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗